Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b

N/AEnrolling By InvitationNCT05352061

University of Miami75 enrolled

Overview

The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Medication Adherence Mental Health Issue

Interventions

CBT for Syndemics and Adherence FactorsBEHAVIORAL

Each hour-long session is conducted via zoom or in person with a study clinician. Sessions focus on HIV medication adherence, coping with life stressors, and managing other challenging situations (e.g., possible traumatic experiences, drug and alcohol use and sexual behavior) that may affect mental or HIV-related health.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 18 years or older 2. HIV positive 3. Evidence of uncontrolled virus (e.g., \> 20 copies/ml) within the past 12 months as verified by medical record 4. Group 1: (Men who have sex with men (MSM) who have used stimulants within the past 4 months (approximately 10 participants))OR Group 2: transgender women (approximately 10 participants) OR Group 3: Emerging adults between the ages of 18 and 26 (inclusive; approximately 10 participants) Exclusion Criteria: 1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview 2. Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation 3. Opinion of the PI that the participant would be at risk for harm to self or others 4. Currently receiving CBT for a psychiatric disorder, or received a course of CBT in the past year.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Percentage of participants who completes the follow up assessment

Feasibility will be reported as the percentage of participants who completes the study follow up assessment.

Time frame: 8 months

Secondary Outcomes

ART Medication Adherence

Antiretroviral Therapy (ART) adherence will be reported as the percentage of participants who reports taking \> 80% of their ART from baseline up to follow up visit.

Time frame: Up to 8 months

Percentage of participants with undetectable viral load

As assessed via serum blood samples.

Time frame: Up to 8 months

Percentage of participants with improvement in syndemic, behavioral health outcomes

Participants with a 2-point reduction in their Diagnostic Interview for Anxiety, Mood and Obsessive Compulsive Disorder (OCD) Related Neuropsychiatric Disorders (DIAMOND) scores from baseline will be reported as having improvement in behavioral health outcome. DIAMOND has a total score ranging from 1-7 with the higher score indicating greater severity.

Time frame: Up to 8 months

Data from ClinicalTrials.gov

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